Heat and passive humidification with filtration between patient and circuit. Designed for use with all ISO compliant airway management systems including ventilators, respirators, and open flow systems where filtration of inspired or expired gases is required such as in hospitals, surgical centers, long term healthcare facilities and the home utilizing anesthesiology or respiratory equipment. Place at anytime on the inspiratory and/or expiratory side of the patient circuit. For single patient use only. For sale by or on the order of a physician.

Device Description

The Series 1 Breathing Circuit Filter is a filter device intended to remove microbiological and particulate matter from the gases in a breathing circuit similar to the SIMS Portex, Inc. Breathing Filter and Filtered HME. The Series 1 Breathing Circuit Filter features include the following: Hydrophobic filter media, Hydrophilic filter media, Sonic welded housing, ISO compliant.

AI/ML Overview

The provided text is a 510(k) Summary for the "Series 1 Breathing Circuit Filter." It describes the device, its intended use, and claims substantial equivalence to another marketed device. However, it does not contain the detailed information necessary to complete a table of acceptance criteria, reported device performance, or details of a study proving the device meets those criteria as requested in your prompt.

Specifically, the document states:

"Substantial equivalence is based on independent laboratory testing performed at Nelson Laboratories and the University of Cincinnati. The Series 1 Breathing Circuit Filter met all standards for filtration and humidity control consistent with industry standards."
"Clinical Data: Not available."

This means:

There's no explicit table of acceptance criteria within this document. The criteria are only broadly referred to as "standards for filtration and humidity control consistent with industry standards."
There are no specific performance metrics provided (e.g., filtration efficiency percentages, pressure drop values).
No details about the "independent laboratory testing" are given (e.g., sample size, ground truth, expert involvement).
There was no clinical study, which would typically involve human subjects or human readers (MRMC, standalone).

Therefore, I cannot provide a complete answer to your request based on the provided text.

To illustrate what a potential answer would look like if the information were available, here's a template, but the fields will be marked as "Not provided in the text" for this specific document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criterion	Reported Device Performance
Filtration (Bacterial)	Not provided in the text	"Met all standards" (details not provided)
Filtration (Viral)	Not provided in the text	"Met all standards" (details not provided)
Humidity Control	Not provided in the text	"Met all standards" (details not provided)
Pressure Drop	Not provided in the text	Not provided in the text
Biocompatibility	Not provided in the text	Not provided in the text

2. Sample size used for the test set and the data provenance
Not provided in the text. The document refers to "independent laboratory testing" but does not specify sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not provided in the text. The testing was laboratory-based, and human expert consensus on ground truth is not applicable for this type of performance testing on a breathing filter.

4. Adjudication method for the test set
Not applicable. The testing was laboratory-based performance testing of a physical device, not an assessment requiring human adjudication of results in the traditional sense (e.g., medical image interpretation).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a physical breathing circuit filter, not an AI diagnostic tool. No human reader study was conducted, and the document explicitly states "Clinical Data: Not available."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical breathing circuit filter, not an algorithm. Performance testing was done on the physical product in a laboratory setting.

7. The type of ground truth used
For the laboratory testing, the ground truth would have been established by standardized laboratory methods and measurements for filtration efficiency and humidity output, not expert consensus, pathology, or outcomes data. Specifics of these ground truth methods are "Not provided in the text."

8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML algorithm. Therefore, there is no "training set."

9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical breathing filter.

Summary

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K012958

FEB 2 2 2002

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510 (K) Summary

Emergency Filtration Products, Inc. 4335 S. Industrial Road Suite 440 Las Vegas, NV 89103 702-798-4541 Telephone 702-798-4939 Fax Douglas K. Beplate, President & Chief Technology Officer 8/27/01 Date Prepared

Trade Name:	Series 1 Breathing Circuit Filter
Common Name:	Breathing Circuit Filter
Classification Name:	Breathing circuit bacterial filter deviceCAH, Class II21CFR868.5260

Emergency Filtration Products, Inc. wishes to introduce to the market the Series 1 Breathing Circuit Filter, a filter device intended to remove microbiological and particulate matter from the gases in a breathing circuit similar to the SIMS Portex, Inc. Breathing Filter and Filtered HME.

The Series 1 Breathing Circuit Filter features include the following:

. Hydrophobic filter media
. Hydrophilic filter media
Sonic welded housing .
ISO compliant .

Intended Use:

The Series 1 Breathing Circuit Filter is a filter device designed for use with all ISO compliant airway management systems including ventilators, respirators and anesthesia circuitry.

Technological Characteristics: None

Substantial Equivalence: Substantial equivalence is based on independent laboratory testing performed at Nelson Laboratories and the University of Cincinnati. The Series 1 Breathing Circuit Filter met all standards for filtration and humidity control consistent with industry standards.
Clinical Data: Not available.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2002

Mr. Douglas Beplate Emergency Filtration Products, Inc. 4335 South Industrial Road, Suite 440 Las Vegas, NV 89103

Re: K012958

Series 1 Breathing Circuit Filter Regulation Number: 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II (two) Product Code: CAH Dated: November 27, 2001 Received: January 10, 2002

Dear Mr. Beplate:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations) in the enactment date of the Medical Device Amendments, or to commerce proc to Hile) 20, 2017 11:15 pm accordance with the provisions of the Federal Food, Drug, de noos that have been that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrororo, mainer of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your device is exassinon (controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Douglas Beplate

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quind by of every of ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promatics noticated device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D.

Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K012958

Device Name: Breathing Circuit Filter

Indications For Use:

Heat and passive humidification with filtration between patient and circuit. Designed for Fical and passive namidines, and open flow systems where filtration of inspired or expired gases is required such as in hospitals, surgical centers, long term mispirod or expired gasses to required utilizing anesthesiology or respiratory equipment. neathireare tacintros and the inspiratory and/or expiratory side of the patient circuit. Flace at hiacmine one on the mopinatese only. For sale by or on the order of a physician.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012458

Prescription Use
(Per 21 CFR 801.109)

Over the Counter Use __________

(Optional Format 1-2-96)

Regulation Number and Section

§ 868.5260 Breathing circuit bacterial filter.

(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).